After Merck & Co.’s Keytruda-chemo combo turned up a mammoth survival advantage back in April, industry watchers fully expected it to win a full approval in previously untreated non-small cell lung cancer. What they may not have expected was how quickly it would happen, thanks to a brand-new FDA approach to cancer-drug reviews.
Monday, the FDA expanded Keytruda’s label to include data showing that, when combined with Eli Lilly’s Alimta and platinum chemo, the drug could cut the risk of death by half versus solo chemo. With the move, U.S. regulators converted Keytruda’s accelerated approval—granted last May on phase 2 data—to a full one.
The green light from the FDA was the second under the agency’s “real time oncology review” pilot program, which allowed its review team to start analyzing Merck’s data after they became public at April’s American Association for Cancer Research (AACR) annual meeting—in other words, before the New Jersey drugmaker actually submitted its application to expand the drug's label.
The first go-ahead under the program came just over a month ago, when the FDA OK’d two new uses for Novartis' breast cancer-fighter Kisqali.
“The pilot focuses on early submission of data that are the most relevant to assessing safety and effectiveness of the product. Then, when the sponsor submits the application with the FDA, the review team will already be familiar with the data and in a better position to conduct a more efficient, timely, and thorough review,” the FDA explained at the time.
The program is sure to prove popular among drugmakers; for one, letting the FDA get its hands on the data earlier allows the agency to “provide feedback to the sponsor on how they can most effectively analyze the data to answer key regulatory questions,” the FDA said. And quicker approvals obviously allow pharma companies to start bringing in sales sooner, too.
Meanwhile, Merck’s label update officially slams the door on what analysts once called “conspiracy theories” from investors worried Merck’s phase 3 data wouldn’t confirm Keytruda’s benefit—and thus wouldn't support a full approval. It also cements Keytruda’s place at the top of the immuno-oncology heap; the drug is the only one in its class of immuno-oncology therapies to bear even one indication in the ultra-lucrative first-line lung cancer market, and it has two.